Regulation Manager

Job Description: 
1. Provides regulatory guidance to all company department
2. In charge of preparation and submission of regulatory agency applications, reports, or correspondence.
3. Provide responses to regulatory agencies regarding product information or issues
4. Maintain current knowledge of relevant regulations, including proposed and final rules.
5. Develop and maintain standard operating procedures or local working practices.
6. Manage activities such as audits and regulatory agency inspection.
7. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
8. Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
9. Plans and overviews V&V activities
10. Participate in the development or implementation of clinical trial protocols.
11. Plans and overviews post marketing activities
12. Oversees QA activities 
Requirements:
1. Familiar with MDR, FDA 510(k) submission
2. Familiar with ISO 13485:2016, IEC 60601-1, IEC 62304
3. BSc. in a relevant field
4. At least 5 years experience